ICECURE MEDICAL LTD

Address:7 HaEshel street, POB 3163,Caesarea Northern,IL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Unit, Cryosurgical, Accessories (GEH) (9) Guide, Needle, Surgical (GDF) (1)

Premarket Exempt

No Yes

Clear

Cryoprobe D3.4 mm/10G, 127 mm, Trocar, Spheric. - 07290015487023 Catalog Number : FAP7100000

Device Description : Cryoprobe - Use only with IceCure Cryogenic device.

Device Class : 2

Duns Number: 514758619

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryoprobe D3.4 mm/10G, 140 mm, Trocar, Elliptic. - 07290015487030 Catalog Number : FAP7200000

Device Description : Cryoprobe-Use only with IceCure Cryogenic Device

Device Class : 2

Duns Number: 514758619

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryoprobe D2.4 mm/13G, 124 mm, Trocar, Spheric. - 07290015487047 Catalog Number : FAP7600000

Device Description : Cryoprobe-Use only with IceCure Cryogenic Device

Device Class : 2

Duns Number: 514758619

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryoprobe D2.4 mm/13G, 134 mm, Trocar, Elliptic. - 07290015487054 Catalog Number : FAP7800000

Device Description : Cryoprobe-Use only with IceCure Cryogenic Device

Device Class : 2

Duns Number: 514758619

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Temperature Sensor - 07290015487061 Catalog Number : FAT8000000

Device Description : Temperature Sensor - Use only with IceCure Cryogenic device

Device Class : 2

Duns Number: 514758619

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryoprobe D2.4 mm/13G, 180 mm, Trocar, Elliptic. - 07290015487078 Catalog Number : FAP7820000

Device Description : Cryoprobe-Use only with IceCure Cryogenic Device

Device Class : 2

Duns Number: 514758619

Premarket Exempt : Yes

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryoprobe D3.4 mm/10G, 185 mm, Trocar, Elliptic. - 07290015487085 Catalog Number : FAP7410000

Device Description : Cryoprobe-Use only with IceCure Cryogenic Device

Device Class : 2

Duns Number: 514758619

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic. - 07290015487092 Catalog Number : FAP7400000

Device Description : Cryoprobe-Use only with IceCure Cryogenic Device

Device Class : 2

Duns Number: 514758619

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryoprobe D3.4 mm/10G, 285 mm, Pencil, Elliptic. - 07290015487108 Catalog Number : FAP7910000

Device Description : Cryoprobe-Use only with IceCure Cryogenic Device

Device Class : 2

Duns Number: 514758619

Premarket Exempt : Yes

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Introducer D2.5 mm, 115 mm, Trocar. - 07290015487115 Catalog Number : FAC9000000

Device Description : Consists of Mandrel (FAC9000000-1) and Canuula (FAC9000000-2)

Device Class : 1

Duns Number: 514758619

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

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